Cervidil

NOTICE: This Consumer Medicine Information (CMI) is intended for persons
living in Australia. This page contains answers to some common
questions about Cervidil. It does
not contain all the information that is known about
Cervidil. It does not take the
place of talking to your doctor or pharmacist. All medicines have risks
and benefits. Your doctor has weighed the risk of you using this medicine
against the benefits he/she expects it will have for you. If you have
any concerns about using this medicine, ask your doctor or pharmacist.
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What CERVIDIL® is used for

CERVIDIL® is for women who have a normal pregnancy and are near their due date for delivery. It is used to prepare for induction.

CERVIDIL® is a pessary (vaginal insert) containing dinoprostone, also known as Prostaglandin E2 or PGE2. Prostaglandin E2 also occurs
naturally in the body. Prostaglandin E2 is important for the changes that take place before labour begins.

CERVIDIL® is used to prepare the cervix (the neck of the womb, at the top of the birth canal) to allow the baby to pass through. This
process is called "cervical ripening".

This medicine is available only with a doctor's prescription.

Your doctor may have prescribed CERVIDIL® for another purpose.

Ask your doctor or midwife if you have any questions about why CERVIDIL® has been prescribed for you.

How it works

CERVIDIL® works by:

softening and opening the cervix (neck of the womb)

setting off contractions (in the body of the womb)

releasing dinoprostone continuously to the cervix at the appropriate rate.

This allows softening and opening of the cervix to progress.

When the doctor decides no further dinoprostone is required, the pessary (vaginal insert) is removed by pulling on the withdrawal
tape.

Before you are given CERVIDIL®

Your doctor will decide if CERVIDIL® is suitable for you.

CERVIDIL® should be administered only by trained personnel, in hospital, with appropriate obstetrical care and facilities for the required
monitoring.

When you must not be given it

You must not be given CERVIDIL® if you have an allergy to dinoprostone or any of the ingredients (e.g. urethane) listed at the end of this leaflet.

Symptoms of an allergic reaction may include:

shortness of breath, wheezing or difficulty breathing

swelling of the face, lips, tongue or other parts of the body

rash, itching or hives on the skin.

You must not be given CERVIDIL® if:

you are carrying more than one baby

your labour has already started

your waters have broken

the doctor has ruptured your membranes (known as amniotomy)

there is any reason why you should not have a vaginal delivery, for example, genital herpes

the baby's head is not well down in the pelvis

the baby is not in the normal position for birth, or

if it is suspected, or tests show, your baby is unwell or not growing, or

the head of the baby is too big or the size of your pelvis is too small for normal delivery, or

you have contractions that are unusually strong and/or long (known as "hypertonic contractions" or "hyperstimulation of the
uterus").

You must not be given CERVIDIL® if you have had any of the following:

previous surgical operation on the womb, for example, a caesarean section, or

surgery to the neck of the womb (cervix), or

previous rupture of the cervix

any vaginal discharge or unexplained vaginal bleeding during the current pregnancy

more than three full term deliveries.

You must not be given CERVIDIL® if you have untreated pelvic inflammatory disease

(also known as PID); usually caused by an infection of the internal female sex organs; it may result in, for example, pain
and tenderness of the stomach and fever.

You should not be given CERVIDIL®:

if the packaging is torn or shows signs of tampering

after the expiry date (EXP) printed on the pack

If you are not sure whether you should be given CERVIDIL®, talk to your doctor.

Taking other medicines

Tell your doctor or midwife if you are taking/using any other medicines, including any that you buy without a prescription
from your pharmacy, supermarket or health food shop. Some medicines and CERVIDIL® may interfere with each other.

Your doctor or midwife may have more information on medicines to be careful with or avoid while using CERVIDIL®.

You must not be given CERVIDIL® if you are being given, or are to be given intravenously within the next thirty minutes, medicines to make the muscles of
your womb contract or bring labour, e.g. oxytocin.

Medication with aspirin and other non-steroidal anti-inflammatory drugs (known as NSAIDs) should be stopped before administration
of CERVIDIL®. Some examples of NSAIDs are Naprosyn and Voltaren.

Tell your doctor or midwife if you have allergies to:

any other medicines

any other substances, such as foods, preservatives or dyes.

Before you are given CERVIDIL® tell your doctor or midwife if you are over 35 years of age or if you have had any medical conditions, especially the following:

lung, liver or kidney problems

asthma

epilepsy (convulsions or fits)

unexplained genital bleeding during current pregnancy

glaucoma (raised pressure in the eye)

abnormally strong contractions of your womb during previous labour, or

previous excessively short labour and delivery time

heart or blood pressure problems

previous complications during pregnancy

gestational diabetes

your pregnancy is past 40 weeks gestation.

When CERVIDIL® must be removed

The pessary (vaginal insert) should be removed immediately:

if contractions are considered too sustained or excessive, or

if labour commences.

It should also be removed

prior to amniotomy

after the waters break (spontaneous rupture of the membranes)

if there is any suggestion of maternal or fetal complications, or

if unwanted side-effects occur

if, after 12 hours the cervix has not changed adequately for delivery.

How CERVIDIL® is given

How much is given

CERVIDIL® is given as one pessary (vaginal insert) inserted once only. Each CERVIDIL® insert contains 10 mg dinoprostone.

Over the maximum recommended usage period of 12 hours, the insert gradually releases dinoprostone.

Over the maximum recommended usage period of 12 hours, the insert gradually releases about 4 mg of dinoprostone.

How it is given

CERVIDIL® must only be given under the supervision of a doctor.

CERVIDIL® is inserted into the vagina. The pouch containing the active ingredient is positioned up at the top of the vagina behind
the cervix. This is called the "posterior fornix".

The tape for withdrawal hangs from the entrance to the vagina.

Before CERVIDIL® is used, careful assessment of the cervix is necessary.

After insertion of CERVIDIL® the following must be monitored regularly:

changes in the cervix

presence or absence of contractions

frequency, duration and strength of contractions

fetal condition

baby's health.

If there is any suggestion of maternal or fetal complications, or if adverse effects occur, the CERVIDIL® pessary (vaginal insert) should be removed. This is done by gently pulling on the withdrawal tape, until the whole device
is removed from the vagina.

Administration

CERVIDIL® looks like a small slim tampon, with a very long attached tape. CERVIDIL® must not be used without this tape, which is used to withdraw the pessary (vaginal insert).

Your doctor or midwife will coat the CERVIDIL® with a little lubricating jelly before putting it in your vagina. The tampon-like end, which holds the medicine, is placed
behind the neck of the womb (cervix), in the area known as the "posterior fornix" of the vagina. The medicine gradually passes
from the device into the upper vagina. The continuing concentration of medicine in the fluids around the cervix causes the
cervix to become softer and gradually open.

The attached withdrawal tape is left hanging out of the entrance to your vagina. Your doctor or midwife can therefore easily
pull out the CERVIDIL® pessary (vaginal insert) when it is time to do so, or if it needs to be removed for any reason.

While you are being given CERVIDIL®

Things you must do

You will be lying down while CERVIDIL® is put in. You should remain lying down for at least 30 minutes afterwards. Your doctor or midwife will advise you when you
can get up again. The pessary (vaginal insert) should be left in place for no longer than 12 hours.

While the pessary (vaginal insert) is in place, you will be checked frequently. Examples of what is being checked include
but are not limited to:

the neck of the womb (cervix)

the strength and frequency of any contractions

the health of your unborn baby.

Removal

The pessary (vaginal insert) is removed by gently pulling the withdrawal tape.

How long it is used for

Your doctor or midwife will remove the pessary (vaginal insert) when you no longer need it or after 12 hours.

For example, they may remove it because:

your labour has started

your doctor wants to use a different medicine to help your womb (uterus) contract e.g. oxytocin

your waters have broken

your uterus is contracting too strongly

your baby is starting to get distressed.

OVERDOSAGE

Your medical attendants will be alert for any signs of overdose. Your doctor, midwife or pharmacist have information on how
to recognise and treat an overdose. Initial treatment of overdose is removal of the pessary (vaginal insert). Other treatment
is also available.

Contact the Poisons Information Centre on 131 126 for further advise on overdose management.

Side effects

Tell your doctor or midwife as soon as possible if you do not feel well while you are being given CERVIDIL®.

All medicines can have side effects. Sometimes they are serious, most of the time they are not.

In most people, CERVIDIL® helps prepare the cervix (neck of womb) for birth. It may have unwanted side effects in a few people.

Tell your doctor if you notice any of the following and you are worried:

diarrhoea.

This side effect is usually mild.

Tell your doctor or midwife immediately if you notice any of the following:

nausea or vomiting

very strong or very frequent contractions of the womb

bleeding, possibly from multiple sites of your body

bluish coloration of the fingers

sudden bruising.

Your doctor may decide to remove the CERVIDIL® pessary (vaginal insert) if these side effects occur.

Tell your doctor or midwife if you notice any other side effects.

Rarely, rupture of the womb has been reported in association with the use of CERVIDIL®. However, most of these patients should not have been given CERVIDIL®. See the section beginning "When you must not be given it" above.

Do not be alarmed by this list of possible side effects.

You may not experience any of them.

Ask your doctor or midwife to answer any questions you may have.

Product description

What it looks like

The CERVIDIL® pessary (vaginal insert) is:

a thin, flat rectangle, with rounded corners

slightly thicker than a large postage stamp

beige in colour

contained within a pouch

made so that, when the pouch becomes moist, the active ingredient (dinoprostone) comes out very slowly. The pouch forms one
end of a long tape

pouch and tape are made of knitted polyester (off-white in colour)

tape allows withdrawal of the insert at the end of dosing.

NOTE: After recommended use, when CERVIDIL® is removed from the vagina, the tampon-like end will have become larger. It absorbs fluid and becomes 2-3 times its original
size.

Ingredients

Pessary (vaginal insert)

The active ingredient in CERVIDIL® is dinoprostone.

The active ingredient is within a plastic (polyurethane) sustained release insert which contains:

hexanetriol/macrogol

8000/isocyanate

cross-linked hydrogel copolymer

The insert is held within a pouch in continuity with a withdrawal tape. Pouch and tape are made of knitted polyester yarn.

Presentation

CERVIDIL® is in an aluminium/polyethylene foil sachet, each containing 1 pessary (vaginal insert).

Storage

CERVIDIL® is kept in a freezer and removed immediately before use. It is store in the hospital.

Disposal

The used pessary (vaginal insert) should be disposed of as clinical waste.

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